China unveils five-year drug safety plan

07-Dec-2011

China formally adopted new measures designed to increase the safety and security of its internal pharmaceutical market at a meeting of the State Council today.

The 2011-2015 National Drug Safety Plan highlights a number of problems facing the pharmaceutical sector, including weak regulatory oversight - despite recent measures to boost adherence to Good Manufacturing Practices (GMP) - as well as inadequacies in technical support functions.

"Drug safety is still in a high-risk period," said the Council in a statement issued after the meeting, which was chaired by Chinese Premier Wen Jiabao.

From a security perspective, the Plan calls for acceleration in the revision of laws and regulations governing the distribution of medicines, including a "severe crackdown" on counterfeit and other illegal medicines and strengthening of enforcement powers.

Among the other objectives outlined in the document is a target of 100 per cent adherence to China's new GMP rules by 2015, which should help to raise patient safety significantly, as well as continuous improvements in chemical and biological standards.

The Council also wants to boost the inspection activities of the State Food and Drug Administration (SFDA) for manufacturing and clinical facilities, particularly in rural areas, and boost laboratory capacity across the country for quality testing of western and traditional Chinese medicines (TCM).

China needs to implement a robust monitoring and warning system for adverse drug reactions, particularly for new, higher-risk medicine and TCM given by injection, and also improve emergency plans to ensure the availability of essential medicines, it said.


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